Manager, Regulatory Affairs, CMC

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Iovance Biotherapeutics, Inc.

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501 - 1000 employés

Fondée en 2014

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Iovance Biotherapeutics, Inc. est à la pointe d'une approche révolutionnaire pour traiter le cancer en exploitant la capacité du système immunitaire humain à reconnaître et attaquer diverses cellules cancéreuses chez chaque patient. La société se concentre sur l'immunothérapie basée sur les cellules T, plus précisément sur la thérapie des lymphocytes infiltrant les tumeurs (TIL), qui consiste à revitaliser les TIL d'un patient pour lutter contre le cancer. La thérapie TIL d'Iovance fait l'objet d'essais cliniques sur plusieurs cancers à tumeurs solides avancées. De plus, l'entreprise développe des thérapies TIL génétiquement modifiées et explore les applications potentielles de la thérapie par lymphocytes du sang périphérique (PBL) pour les cancers du sang. En tant que leader de la thérapie cellulaire, Iovance possède un centre de thérapie cellulaire de pointe à Philadelphie pour la fabrication de leurs thérapies en utilisant un GMP propriétaire. L'entreprise est à l'avant-garde du développement de traitements contre le cancer, personnalisés et spécifiques à chaque patient.

Description

• Manages the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments. • Prepares routine IND and CTA amendments. • Work with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule. • Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects and topics. • Interface with Quality Assurance, clinical manufacturing, commercial manufacturing and other stakeholders to further develop and maintain a robust change control program. • Work with cross-functional project teams to develop CMC regulatory strategy for product changes at all stages of development. • Work within the CMC Regulatory Affairs team to gain consensus on proposed changes. • Negotiate with internal stakeholders to ensure that proposed changes and submission content are aligned with ICH guidelines, country regulations and guidelines, and industry standards. • Participate in risk mitigation by proactively identifying risk, developing options and contingency plans. • Assists in developing and managing Gantt charts (in conjunction with Program Management) and trackers for submissions across the multiple products. • Maintains logs of IND and CTA submissions and correspondence with FDA or other regulatory agencies. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned.

🎯 Exigences

• BA/BS degree in related field required. • At least 8 years’ experience in regulatory affairs or a related function in drug/biologic development. • Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format. • Broad understanding of international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements. • Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships. • Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro. • High attention to detail and accuracy. • Excellent interpersonal, verbal and written communication skills. • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

🏖️ Avantages

• Reasonable accommodations may be made upon request to enable individuals to perform essential functions.